Axsome (AXSM.US) rises in pre-market trading! Its depression therapy expands indications and receives FDA priority review.

Focused on developing and commercializing novel therapies for central nervous system (CNS) diseases, biopharmaceutical company Axsome Therapeutics (AXSM.US) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has granted priority review status to its submitted supplemental new drug application aimed at expanding the indication of its depression therapy AXS-05 (trade name: Auvelity) to agitation symptoms in Alzheimer's disease. The company stated in a release that the FDA has set a target action date of April 30, 2026 for the supplemental new drug application for AXS-05. Boosted by this news, Axsome's pre-market stock rose over 7% as of the time of writing on Wednesday. In 2022, the FDA approved AXS-05 for the treatment of severe depression in adults. In 2020, the FDA granted breakthrough therapy designation for the drug in treating agitation symptoms in Alzheimer's disease. Alzheimer's disease (AD), also known as senile dementia, is a common neurodegenerative disease with complex pathogenesis, characterized mainly by memory decline, cognitive impairment, and behavioral abnormalities. It has been reported that agitation symptoms are present in over half of AD patients, characterized by emotional distress, verbal and physical aggression, destructive irritability, and disinhibition. Agitation is a neuropsychiatric symptom in AD patients, typically appearing early in the disease course and persisting, leading to increased healthcare costs, significant burden on caregivers, and increased suffering for patients. AXS-05 (dextromethorphan-bupropion) is an oral N-methyl-D-aspartate receptor antagonist, sigma-1 receptor agonist, and cytochrome P450 2D6 inhibitor. AXS-05 utilizes patented formulations and doses of dextromethorphan and bupropion, along with Axsome's metabolic inhibition technology, to modulate ingredient delivery. The dextromethorphan component of AXS-05 is a non-competitive NMDA receptor antagonist, also known as a glutamate receptor modulator and sigma-1 receptor agonist. The bupropion component of AXS-05 is used to increase the bioavailability of dextromethorphan and acts as a norepinephrine and dopamine reuptake inhibitor. This novel therapy is expected to improve agitation symptoms in AD characterized by emotional distress, verbal and physical aggression, destructive irritability, and disinhibition. Axsome's CEO, Herriot Tabuteau, stated, "We are very pleased that the FDA has accepted and granted priority review to our supplemental new drug application aimed at treating agitation symptoms in Alzheimer's disease with AXS-05. We look forward to continuing to collaborate with the FDA in the upcoming review stage."